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By: gatorbak
11 Dec 2003, 06:56 PM EST
Msg. 130689 of 130714
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ADVR Reports Positive Preliminary Results of AVR118 Clinical Trial in AIDS Patients Suffering from Body Wasting (Cachexia)
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10 November 2003, 08:21am ET

Patients Show Improved Appetite, Weight Stability or Gains,
and Enhanced Quality of Life
YONKERS, N.Y., Nov. 10 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (BB:ADVR) today reported that preliminary results from the first 15 cachectic (wasting) AIDS patients treated with the Company's novel immunomodulator AVR118 showed improvement in appetite, weight gain or stability, and enhanced quality of life in all the patients. None of the 15 patients reported any significant side effects from AVR118 (formerly known as Product R) therapy. Cachexia is a state of body malnutrition and wasting with loss of body fat and lean body weight.

The 15 patients who completed the trial included eight males, five on highly active antiretroviral therapy (HAART), and seven females, five of whom were receiving HAART. The primary indication of the trial is the treatment of cachexia (body wasting). The patients are part of a Phase I/Phase II open- label dose escalation clinical trial being conducted at The Kaplan Medical Center in Rehovot, Israel.

"We have taken the unusual step of publicizing these preliminary results, despite the small population of patients, because of the apparent strong clinical results demonstrated, even in this short course treatment protocol, by AVR118 in these very ill patients," said Eli Wilner, Chairman of the Board of ADVR. "If the continuation of the study confirms these preliminary findings, the value of AVR118 in treating body wasting in AIDS patients will merit much broader scientific analysis in a large study of AIDS patients."

"These preliminary results are very encouraging because a positive clinical effect was seen in virtually all patients following initiation of treatment with AVR118, even at the lowest dosage," said James D'Olimpio, M.D., Director of the North Shore University Hospital's Supportive Oncology and Palliative Care Service, and a member of ADVR's Scientific Advisory Board. "The study design and quality of data is worthy of a presentation at an appropriate international scientific meeting. I would encourage the investigators to prepare an abstract once the statistical analysis of the data set is completed so that these promising preliminary results can be shared with the global scientific community." Dr. D'Olimpio has done extensive research on cachexia, particularly in cancer patients.

Mentioned Last Change
ADVR 0.22 0.01dollars or (4.76%)
When completed, the clinical trial will include a total of 30 patients, with 10 each receiving AVR118 administered subcutaneously per day at the three doses of 0.4 ml, 2 ml, and 4 ml. The trial protocol specifies a two-week preliminary observation period followed by four weeks of AVR118 therapy and four weeks of observation.

"The preliminary results demonstrate the potential utility of AVR118 in this group of patients," said Richard A. Guarino, M.D., ADVR's clinical and regulatory advisor.

"These preliminary results in cachectic AIDS patients are encouraging, and I eagerly await possible confirmation of our preliminary results once all 30 patients have completed the trial," said Shalom Z. Hirschman, M.D., ADVR's Chief Scientist. "These results garnered midway through the clinical trial appear to validate our expectations of the clinical activity of the unique immunomodulator AVR118."

ADVR's AVR118 represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Therefore, AVR118 has been termed a "switch-type" immunomodulator. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.

For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com .

Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases.

Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 (Product R) is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Eli Wilner

SOURCE Advanced Viral Research Corp.
-0- 11/10/2003
/CONTACT: Eli Wilner, +1-914-376-7383, for Advanced Viral Research Corp./
/Company News On-Call:


/Web site:



CO: Advanced Viral Research Corp.
ST: New York

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